EP1718239B1 - Implantable prosthesis for repairing hernia defects - Google Patents

Implantable prosthesis for repairing hernia defects Download PDF

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Publication number
EP1718239B1
EP1718239B1 EP05707568A EP05707568A EP1718239B1 EP 1718239 B1 EP1718239 B1 EP 1718239B1 EP 05707568 A EP05707568 A EP 05707568A EP 05707568 A EP05707568 A EP 05707568A EP 1718239 B1 EP1718239 B1 EP 1718239B1
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EP
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Prior art keywords
prosthesis according
thread
basic structure
prosthesis
fixing
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German (de)
French (fr)
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EP1718239A1 (en
Inventor
Hanngörg ZIMMERMANN
Markus Heinlein
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GfE Medizintechnik GmbH
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GfE Medizintechnik GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes

Definitions

  • the invention relates to an implantable prosthesis for the repair of hernia defects or comparable soft tissue defects with a base body made of a reticulated, in particular knitted, layer material which is deformable into a plug-like insert which can be positioned in the hernia defect.
  • hernia plug Such prostheses, which are referred to in the jargon as “hernia plug” or “hernia plug” are known in many different embodiments.
  • a hernia plug consisting of tapered plug-in plug elements.
  • the plug elements are each provided by pleating with a conical, folded in wall.
  • the hernia plug shown there is particularly complex in its construction and production, since each individual element conically pleated, the individual elements inserted into one another and then fixed to each other.
  • the object of the invention is to design an implantable prosthesis for the repair of hernia defects in such a way that it can be constructed much simpler without significant losses in its therapeutic effects and can be produced with a correspondingly low production cost, while being easy and safe to handle during the implantation.
  • the main body of the prosthesis from a preferably round to oval blank of the sheet material formed, which is placed in parallel zigzag folds.
  • the advantage over the prior art is that only one material layer is necessary for the production of the main body.
  • the zig-zag folds which are also present according to the invention are only approximately centered relative to the selected direction of extension by means of a fixation that passes through the fold layers such that the base body in its undeformed rest position is slightly hourglass-shaped in plan view.
  • the waist of this configuration is due to the fixation of the pleat layers to each other, from where the zig-zag pleats more or less leak towards the edge of the blank.
  • this prosthesis configuration is particularly simple; the prosthesis is grasped in the region of the central fixation with two fingers and deformed in a pleat-like manner while bending over the remaining areas.
  • the "gathering" of the wrinkles in the central region of the prosthesis also generates high restoring forces against the above-mentioned deformation, resulting in an effective spreading of the prosthesis in the hernia defect.
  • the central fixation of the zig-zag folds furthermore allows the layer material to widen again with increasing distance from the fixation, so that the hourglass-shaped configuration of the basic body is produced in its undeformed rest position.
  • the "gusset" in the fixation is due to its constricted form particularly good thumb and forefinger for insertion into the hernia defect to seize, so that the prosthesis according to the invention also offers handling advantages for the surgeon in the application.
  • a particularly effective and reliable, easy to apply fixation of the zig-zag folds is given according to the preferred embodiments according to claims 2 to 4 by the use of a fixing thread.
  • the fixing seam formed by the fixing thread preferably extends transversely to the direction of extension of the folds and transversely to the main extension plane of the undeformed prosthesis.
  • the fixing thread is preferably made of the same plastic material - preferably polypropylene - as the layer material thread.
  • the entire prosthesis consists of a completely uniform base material, which entails a considerable simplification under regulatory law.
  • the prostheses according to the invention are produced only by manufacturing processes of the classical textile production, namely cutting, folding and sewing. More complex production processes, such as pleating, spraying or casting, preforming of flat blanks into a conical basic structure and the like, are avoided.
  • the prosthesis is drapeable, soft and easily approachable to hernia mesh.
  • the substantially two-dimensional main body of the prosthesis may be reshaped into a three-dimensionally deformed, plug-like configuration by preferably connecting the adjacent side edge zones on both sides of the constriction by a suture of the same suture material as the ply thread. In that regard, therefore, the "purity of type" of the materials used for the prosthesis is retained.
  • a surface metallization preferably a titanium-containing Coating
  • the hernia plug according to the invention is particularly compatible.
  • Another advantage of the surface metallization lies in the associated hydrophilization of the net material of the plug, as a result of which it sucks, as it were, against the walls of the hernia defect to be supported. Because of the mechanical expansion, the fixation of the hernia plug in the defect is further improved.
  • the fabrication of the hernia plug from a single-layer mesh material has finally in connection with the surface metallization the advantage that despite the folding the entire mesh surface remains relatively accessible, so the metallization process such as using a PACVD method, as shown in DE 199 45 299 A is known, is feasible nationwide and leads to a closed metallization on the plastic mesh material. This further benefits the tissue compatibility of the hernia plug.
  • the hernia plug shown consists of a net-like layer material 1, which is chain-knitted, for example, from a polypropylene monofilament with a thread thickness of 100 dtex in Atlas lapping.
  • the basis weight of this layer material 1 is about 60-65 g / m 2 .
  • This will - as in FIG. 1 represented by a dashed line - one in its basic form oval, with lateral constrictions 11 cut out in the middle region hourglass-shaped blank 10 by means of laser cutting on a corresponding web material.
  • This blank is placed in the longitudinal axis of the oval basic shape parallel to the longitudinal direction 2 in zig-zag folds 3, as shown in Fig. 2 is shown schematically.
  • a folding seam 4 by means of a monofilament thread 5 is inserted in the middle of the longitudinal extension direction 2 for fixing the zig-zag folds 3.
  • This thread 5 is identical to the thread material that has been processed into the layer material 1, ie consists of the same polypropylene granules and has an identical thread thickness of 100 dtex.
  • the seam direction N extends transversely to the longitudinal extension 2 (FIG. Fig. 1 ) and to the main plane H of the main body 6 ( Fig. 2 ).
  • the prefabricated as above basic body 6 is - as out Fig.
  • the main body 6 After assembly by means of a PACVD process known from the prior art, the main body 6 is provided with a continuous titanization covering the entire surface, whose specification has already been specified in the introduction to the description.
  • the base body 6 In clinical use for repairing a hernia defect, the base body 6 is grasped in the region of the gusset formed by the fixing seam 4 and inserted into the hernia opening. In this case, the body deforms to a plug-like use and spreads due the particular the wrinkles inherent restoring forces in the opening.
  • Fig. 4 illustrated variant of the hernia plug is directly from the embodiment according to Fig. 1 to 3 originated by the in Fig. 1 provided with the reference numeral 8, adjacent side edge zones brought into overlap by deformation of the base body 6 and with a seam 9 (dashed lines indicated in FIG Fig. 4 ).
  • the base body is already fixed in the plug-like configuration in which it is used to repair a hernia defect.
  • the thread material of the seam 9 is identical to that used for the fixing seam 4 in the region of the zig-zag folds 3, whereby this variant is also made of a uniform material.
  • Fig. 4 illustrated embodiment of the hernia plug is provided after shaping in the manner shown with a titanium-containing coating a thickness of ⁇ 2 microns, preferably from 5 to 700 nm. Practical values of the coating thickness are 20 to 30 nm.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

An implantable prosthesis for repairing hernia defects comprises a basic structure ( 6 ) which is provided with concertina pleats ( 3 ) that are parallel to a direction of extension. They are fixed by a fixing arrangement so that the basic structure ( 6 ) is approximately hourglass-shaped in a plan view.

Description

Die Erfindung betrifft eine implantierbare Prothese zur Reparatur von Herniendefekten oder vergleichbaren Weichgewebedefekten mit einem Grundkörper aus einem netzförmigen, insbesondere gewirkten Lagenmaterial, der zu einem stopfenartigen, in den Herniendefekt positionierbaren Einsatz deformierbar ist.The invention relates to an implantable prosthesis for the repair of hernia defects or comparable soft tissue defects with a base body made of a reticulated, in particular knitted, layer material which is deformable into a plug-like insert which can be positioned in the hernia defect.

Derartige Prothesen, die im Fachjargon auch als "Hernien-Stopfen" oder "Hernien-Plug" bezeichnet werden, sind in vielerlei unterschiedlichen Ausführungsformen bekannt. Als Beispiel kann auf die US 5 716 408 A1 , worauf der Oberbegriff des Anspruchs 1 basert, verwiesen werden, die einen Hernien-Plug bestehend aus kegelförmigen, ineinandersitzenden Stopfenelementen offenbart. Die Stopfenelemente sind jeweils durch Plissieren mit einer konischen, in Falten gelegten Wandung versehen. Insoweit ist der dort gezeigte Hernien-Plug in seiner Konstruktion und Herstellung besonders aufwändig, da jedes einzelne Element konisch plissiert, die einzelnen Elemente ineinander gesteckt und anschließend aneinander fixiert werden müssen.Such prostheses, which are referred to in the jargon as "hernia plug" or "hernia plug" are known in many different embodiments. As an example, on the US 5 716 408 A1 to which the preamble of claim 1 is based, which discloses a hernia plug consisting of tapered plug-in plug elements. The plug elements are each provided by pleating with a conical, folded in wall. In that regard, the hernia plug shown there is particularly complex in its construction and production, since each individual element conically pleated, the individual elements inserted into one another and then fixed to each other.

Davon ausgehend liegt der Erfindung die Aufgabe zugrunde, eine implantierbare Prothese zur Reparatur von Herniendefekten so auszugestalten, dass sie ohne signifikante Einbußen bei ihren therapeutischen Wirkungen weitaus einfacher aufgebaut und mit entsprechend geringem Herstellungsaufwand produzierbar, dabei während der Implantation jedoch bequem und sicher handhabbar ist.Based on this, the object of the invention is to design an implantable prosthesis for the repair of hernia defects in such a way that it can be constructed much simpler without significant losses in its therapeutic effects and can be produced with a correspondingly low production cost, while being easy and safe to handle during the implantation.

Diese Aufgabe wird durch die im Kennzeichnungsteil des Anspruches 1 angegebenen Merkmale gelöst. Demnach ist der Grundkörper der Prothese aus einem vorzugsweise runden bis ovalen Zuschnitt des Lagenmaterials gebildet, das in parallel zueinander verlaufende Zick-Zack-Falten gelegt ist. Insoweit ist bereits gegenüber dem Stand der Technik der Vorteil zu nennen, dass lediglich eine Materiallage für die Herstellung des Grundkörpers notwendig ist.This object is achieved by the features stated in the characterizing part of claim 1. Accordingly, the main body of the prosthesis from a preferably round to oval blank of the sheet material formed, which is placed in parallel zigzag folds. In that regard, the advantage over the prior art is that only one material layer is necessary for the production of the main body.

Die ferner erfindungsgemäß vorhandenen Zick-Zack-Falten sind nur etwa mittig bezogen auf die gewählte Erstreckungsrichtung durch eine die Faltenlagen durchgreifende Fixierung derart festgelegt, dass der Grundkörper in seiner undeformierten Ruheposition in Draufsicht etwas sanduhrförmig ausgebildet ist. Die Taille dieser Konfiguration entsteht durch die Fixierung der Faltenlagen zueinander, von wo aus die Zick-Zack-Falten zum Rand des Zuschnitts hin mehr oder weniger stark auslaufen.The zig-zag folds which are also present according to the invention are only approximately centered relative to the selected direction of extension by means of a fixation that passes through the fold layers such that the base body in its undeformed rest position is slightly hourglass-shaped in plan view. The waist of this configuration is due to the fixation of the pleat layers to each other, from where the zig-zag pleats more or less leak towards the edge of the blank.

Von der Handhabung her ist diese Prothesenkonfiguration besonders einfach, die Prothese wird im Bereich der mittigen Fixierung mit zwei Fingern ergriffen und unter Aufbiegen der verbleibenden Bereiche stopfenartig deformiert. Durch die "Raffung" der Falten im zentralen Bereich der Prothese werden ferner hohe Rückstellkräfte gegen die vorstehend erwähnte Deformation generiert, was einem wirksamen Verspreizen der Prothese im Herniendefekt zugute kommen.In terms of handling, this prosthesis configuration is particularly simple; the prosthesis is grasped in the region of the central fixation with two fingers and deformed in a pleat-like manner while bending over the remaining areas. The "gathering" of the wrinkles in the central region of the prosthesis also generates high restoring forces against the above-mentioned deformation, resulting in an effective spreading of the prosthesis in the hernia defect.

Durch die mittige Fixierung der Zick-Zack-Falten kann sich ferner das Lagenmaterial mit zunehmenden Abstand von der Fixierung wieder breiter legen, sodass die sanduhrförmige Konfiguration des Grundkörpers in seiner undeformierten Ruheposition erzeugt wird. Der "Zwickel" im Bereich der Fixierung ist aufgrund seiner eingeschnürten Form besonders gut mit Daumen und Zeigefinger für das Einsetzen in den Herniendefekt zu ergreifen, sodass die erfindungsgemäße Prothese auch handhabungstechnische Vorteile für den Chirurgen in der Anwendung bietet.The central fixation of the zig-zag folds furthermore allows the layer material to widen again with increasing distance from the fixation, so that the hourglass-shaped configuration of the basic body is produced in its undeformed rest position. The "gusset" in the fixation is due to its constricted form particularly good thumb and forefinger for insertion into the hernia defect to seize, so that the prosthesis according to the invention also offers handling advantages for the surgeon in the application.

Eine besonders wirkungsvolle und zuverlässige, dabei einfach anzulegende Fixierung der Zick-Zack-Falten ist laut den bevorzugten Ausführungsformen gemäß den Ansprüchen 2 bis 4 durch die Verwendung eines Fixierfadens gegeben. Vorzugsweise erstreckt sich die vom Fixierfaden gebildete Fixiernaht quer zur Erstreckungsrichtung der Falten und quer zur Haupterstreckungsebene der undeformierten Prothese. Der Fixierfaden besteht dabei bevorzugtermaßen aus dem gleichen Kunststoffmaterial - vorzugsweise Polypropylen - wie der Lagenmaterialfaden. Dann besteht nämlich die gesamte Prothese aus einem völlig einheitlichen Grundmaterial, was eine erhebliche zulassungsrechtliche Vereinfachung mit sich bringt. Ferner werden bei dieser Ausführungsform mit Fixiernaht die erfindungsgemäßen Prothesen nur durch Fertigungsgänge der klassischen Textilkonfektion, nämlich Zuschneiden, Faltenlegen und Nähen, hergestellt. Es werden komplexere Fertigungsgänge, wie Plissieren, Spritzen oder Gießen, Vorformung von flächigen Zuschnitten in eine konische Grundstruktur und dergleichen, vermieden. Die Prothese ist drapierfähig, weich und auch leicht an Herniennetze annähbar.A particularly effective and reliable, easy to apply fixation of the zig-zag folds is given according to the preferred embodiments according to claims 2 to 4 by the use of a fixing thread. The fixing seam formed by the fixing thread preferably extends transversely to the direction of extension of the folds and transversely to the main extension plane of the undeformed prosthesis. The fixing thread is preferably made of the same plastic material - preferably polypropylene - as the layer material thread. For then the entire prosthesis consists of a completely uniform base material, which entails a considerable simplification under regulatory law. Furthermore, in this embodiment, with fixation seam, the prostheses according to the invention are produced only by manufacturing processes of the classical textile production, namely cutting, folding and sewing. More complex production processes, such as pleating, spraying or casting, preforming of flat blanks into a conical basic structure and the like, are avoided. The prosthesis is drapeable, soft and easily approachable to hernia mesh.

In einer alternativen Ausführungsform können der im Wesentlichen zweidimensionale Grundkörper der Prothese zu einer dreidimensional deformierten, stopfenartigen Konfiguration umgeformt werden, indem die benachbarten Seitenkantenzonen beiderseits der Einschnürung vorzugsweise wiederum durch eine Naht aus dem gleichen Fadenmaterial wie der Lagenmaterialfaden verbunden werden. Insoweit bleibt also die "Sortenreinheit" der für die Prothese verwendeten Materialien erhalten.In an alternative embodiment, the substantially two-dimensional main body of the prosthesis may be reshaped into a three-dimensionally deformed, plug-like configuration by preferably connecting the adjacent side edge zones on both sides of the constriction by a suture of the same suture material as the ply thread. In that regard, therefore, the "purity of type" of the materials used for the prosthesis is retained.

Gemäß einer weiteren bevorzugten Ausführungsform ist die implantierbare Prothese mit einer durchgehenden körperverträglichen Beschichtung in Form einer Oberflächenmetallisierung, vorzugsweise einer Titan-haltigen Beschichtung, versehen. Damit ist der erfindungsgemäße Hernien-Plug besonders verträglich. Ein weiterer Vorteil der Oberflächenmetallisierung liegt in der damit verbundenen Hydrophilierung des Netzmaterials des Plugs, wodurch sich dieser quasi an die Wände des zu stützenden Herniendefekts saugt. Wegen der mechanischen Verspreizung wird damit die Fixierung des Hernien-Plugs im Defekt weiter verbessert.According to a further preferred embodiment, the implantable prosthesis with a continuous body-compatible coating in the form of a surface metallization, preferably a titanium-containing Coating, provided. Thus, the hernia plug according to the invention is particularly compatible. Another advantage of the surface metallization lies in the associated hydrophilization of the net material of the plug, as a result of which it sucks, as it were, against the walls of the hernia defect to be supported. Because of the mechanical expansion, the fixation of the hernia plug in the defect is further improved.

Die Konfektionierung des Hernien-Plugs aus einem einlagigen Netzmaterial hat schließlich im Zusammenhang mit der Oberflächenmetallisierung den Vorteil, dass trotz der Faltenlegung die gesamte Netzoberfläche relativ gut zugänglich bleibt, sodass der Metallisierungsprozess etwa mithilfe eines PACVD-Verfahrens, wie es aus der DE 199 45 299 A bekannt ist, flächendeckend durchführbar ist und zu einer geschlossenen Metallisierungsschicht auf dem Kunststoff-Netzmaterial führt. Dies kommt der Gewebeverträglichkeit des Hernien-Plugs weiter zugute.The fabrication of the hernia plug from a single-layer mesh material has finally in connection with the surface metallization the advantage that despite the folding the entire mesh surface remains relatively accessible, so the metallization process such as using a PACVD method, as shown in DE 199 45 299 A is known, is feasible nationwide and leads to a closed metallization on the plastic mesh material. This further benefits the tissue compatibility of the hernia plug.

Schließlich ist gemäß einer weiteren bevorzugten Ausführungsform vorgesehen, das Lagenmaterial für den Grundkörper mithilfe eines Schneidlasers zuzuschneiden. Da dies auf der Basis eines thermischen Schmelzprozesses erfolgt, hat dies den Vorteil, dass an den Schnittkanten keine "Ausfransungen" mit sich lösenden Faserpartikeln, sondern ein sauber abgeschmolzener Randkantenbereich erzielt werden.Finally, it is provided according to a further preferred embodiment, to cut the sheet material for the body using a cutting laser. Since this is done on the basis of a thermal melting process, this has the advantage that at the cut edges no "fraying" with loosening fiber particles, but a cleanly sealed edge edge region can be achieved.

Zur Herstellung eines in sich stabileren und stärkeren Hernien-Plugs kann gemäß einer weiteren bevorzugten Ausführungsform vorgesehen sein, zwei in Zick-Zack-Falten gelegte und so fixierte Grundkörper kreuzweise aufeinander zu legen und miteinander zu verbinden, so dass die Grundkonfiguration der Prothese im wesentlichen kleeblattförmig ist.In order to produce a more stable and stronger hernia plug, according to another preferred embodiment, it is possible to cross-superimpose and connect two base bodies arranged in zigzag folds so that the basic configuration of the prosthesis is substantially cloverleaf-shaped is.

Ferner kann durch die Verwendung eines in seiner Grundform ovalen, seitlich mit Einschnürungen versehenen Zuschnittes in vorteilhafter Weise beim Raffen der zentralen Falten und deren Vernähung ein übermäßiges Aufbauschen dort im Zentralbereich der Prothese verhindert werden.Furthermore, the use of a cut in its basic form oval, laterally provided with constrictions in an advantageous manner when shirring the central folds and their suturing an excessive bulging there in the central region of the prosthesis can be prevented.

Weitere Merkmale, Einzelheiten und Vorteile des Erfindungsgegenstandes sind der nachfolgenden Beschreibung entnehmbar, in der Ausführungsbeispiele des Erfindungsgegenstandes anhand der beigefügten Darstellungen näher erläutert werden.Further features, details and advantages of the subject invention are the following description can be removed, are explained in more detail in the embodiments of the subject invention with reference to the accompanying drawings.

Es zeigen:Show it:

Fig.FIG.
1 eine Draufsicht auf einen Hernien-Plug,1 is a plan view of a hernia plug,
Fig. 2Fig. 2
einen schematischen Querschnitt entlang der Schnittlinie II-II nach Fig. 1,a schematic cross section along the section line II-II according to Fig. 1 .
Fig. 3Fig. 3
einen schematischen Querschnitt entlang der Schnittlinie III-III nach Fig. 1,a schematic cross section along the section line III-III after Fig. 1 .
Fig. 4Fig. 4
eine perspektivische Darstellung eines Hernien-Plugs in einer zweiten Ausführungsform.a perspective view of a hernia plug in a second embodiment.

Wie aus Fig. 1 deutlich wird, besteht der gezeigte Hernien-Plug aus einem netzartigen Lagenmaterial 1, das beispielsweise aus einem Polypropylen-Monofilament mit einer Fadenstärke von 100 dtex in Atlas-Legung kettengewirkt ist. Das Flächengewicht dieses Lagenmaterials 1 beträgt ca. 60 - 65 g/m2. Daraus wird - wie in Figur 1 durch eine strichlierte Linie dargestellt ist - ein in seiner Grundform ovaler, mit seitlichen Einschnürungen 11 im Mittenbereich sanduhrförmig gestalteter Zuschnitt 10 mittels Laserschneiden auf einem entsprechenden Bahnmaterial herausgeschnitten. Dieser Zuschnitt wird in zur langen Achse der ovalen Grundform parallelen Längserstreckungsrichtung 2 in Zick-Zack-Falten 3 gelegt, wie dies in Fig. 2 schematisch dargestellt ist. Diese Falten 3 bauschen beim Raffen aufgrund der Einschnürungen 11 im Zuschnitt 10 weniger stark auf wie bei einem vollständig ovalen Zuschnitt. Anschließend wird mittig bezogen auf die Längserstreckungsrichtung 2 zur Fixierung der Zick-Zack-Falten 3 eine die Faltenlagen durchgreifende Fixiernaht 4 mithilfe eines monofilen Fadens 5 gelegt. Dieser Faden 5 ist identisch mit dem Fadenmaterial, das zu dem Lagenmaterial 1 verarbeitet wurde, besteht also aus dem gleichen Polypropylen-Granulat und weist eine identische Fadenstärke von 100 dtex auf. Die Nahtrichtung N verläuft quer zur Längser-streckung 2 (Fig. 1) und zur Hauptebene H des Grundkörpers 6 (Fig. 2).
Der wie vorstehend konfektionierte Grundkörper 6 ist - wie aus Fig. 1 deutlich wird - in seiner undeformierten Ruheposition in Draufsicht etwa sanduhrförmig ausgebildet. Die mittig fixierten Zick-Zack-Falten 3 laufen zu den Längsenden 7 des Grundkörpers 6 hin weich in eine mehr oder weniger zweidimensionale Konfiguration aus (siehe Fig. 3).How out Fig. 1 becomes clear, the hernia plug shown consists of a net-like layer material 1, which is chain-knitted, for example, from a polypropylene monofilament with a thread thickness of 100 dtex in Atlas lapping. The basis weight of this layer material 1 is about 60-65 g / m 2 . This will - as in FIG. 1 represented by a dashed line - one in its basic form oval, with lateral constrictions 11 cut out in the middle region hourglass-shaped blank 10 by means of laser cutting on a corresponding web material. This blank is placed in the longitudinal axis of the oval basic shape parallel to the longitudinal direction 2 in zig-zag folds 3, as shown in Fig. 2 is shown schematically. These folds 3 bulge less when shirring due to the constrictions 11 in the blank 10 as in a completely oval blank. Subsequently, in the middle of the longitudinal extension direction 2 for fixing the zig-zag folds 3, a folding seam 4 by means of a monofilament thread 5 is inserted. This thread 5 is identical to the thread material that has been processed into the layer material 1, ie consists of the same polypropylene granules and has an identical thread thickness of 100 dtex. The seam direction N extends transversely to the longitudinal extension 2 (FIG. Fig. 1 ) and to the main plane H of the main body 6 ( Fig. 2 ).
The prefabricated as above basic body 6 is - as out Fig. 1 becomes clear - formed in his undeformed rest position in plan view about hourglass-shaped. The centrally fixed zig-zag pleats 3 smoothly extend to the longitudinal ends 7 of the main body 6 in a more or less two-dimensional configuration (see Fig. 3 ).

Der Grundkörper 6 wird nach der Konfektionierung mittels eines aus dem Stand der Technik bekannten PACVD-Prozesses mit einer die gesamte Oberfläche bedeckenden, durchgehenden Titanisierung versehen, deren Spezifikation in der Beschreibungseinleitung bereits näher angegeben wurde.After assembly by means of a PACVD process known from the prior art, the main body 6 is provided with a continuous titanization covering the entire surface, whose specification has already been specified in the introduction to the description.

Im klinischen Einsatz zur Reparatur eines Herniendefektes wird der Grundkörper 6 im Bereich des durch die Fixiernaht 4 gebildeten Zwickels ergriffen und in die Hernienöffnung eingeschoben. Dabei deformiert sich der Grundkörper zu einem stopfenartigen Einsatz und verspreizt sich aufgrund der insbesondere den Falten innewohnenden Rückstellkräfte in der Öffnung.In clinical use for repairing a hernia defect, the base body 6 is grasped in the region of the gusset formed by the fixing seam 4 and inserted into the hernia opening. In this case, the body deforms to a plug-like use and spreads due the particular the wrinkles inherent restoring forces in the opening.

Die in Fig. 4 dargestellte Variante des Hernien-Plugs ist direkt aus der Ausführungsform gemäß Fig. 1 bis 3 entstanden, indem die in Fig. 1 mit dem Bezugszeichen 8 versehenen, benachbarten Seitenkantenzonen durch Deformation des Grundkörpers 6 in Überlappung gebracht und mit einer Naht 9 (strichliert angedeutet in Fig. 4) miteinander verbunden werden. Damit ist der Grundkörper bereits in der stopfenartigen Konfiguration fixiert, in der er zur Reparatur eines Herniendefekts eingesetzt wird. Das Fadenmaterial der Naht 9 ist identisch mit dem für die Fixiernaht 4 im Bereich der Zick-Zack-Falten 3 verwendeten, wodurch diese Variante ebenfalls aus einem einheitlichen Material hergestellt ist.In the Fig. 4 illustrated variant of the hernia plug is directly from the embodiment according to Fig. 1 to 3 originated by the in Fig. 1 provided with the reference numeral 8, adjacent side edge zones brought into overlap by deformation of the base body 6 and with a seam 9 (dashed lines indicated in FIG Fig. 4 ). Thus, the base body is already fixed in the plug-like configuration in which it is used to repair a hernia defect. The thread material of the seam 9 is identical to that used for the fixing seam 4 in the region of the zig-zag folds 3, whereby this variant is also made of a uniform material.

Auch die in Fig. 4 dargestellte Darstellungsform des Hernien-Plugs wird nach der Formgebung in der dargestellten Weise mit einer Titan-haltigen Beschichtung einer Dicke von < 2 µm, vorzugsweise von 5 bis 700 nm versehen. Praktische Werte der Beschichtungsdicke liegen bei 20 bis 30 nm.Also in Fig. 4 illustrated embodiment of the hernia plug is provided after shaping in the manner shown with a titanium-containing coating a thickness of <2 microns, preferably from 5 to 700 nm. Practical values of the coating thickness are 20 to 30 nm.

Claims (11)

  1. An implantable prosthesis for repairing hernia defects, comprising a basic structure (6) of meshed, in particular knitted, layer material (1) which is deformable into a plug-type insert capable of being positioned in the hernia defect, wherein the basic structure (6) is a blank (10) of the layer material (1) of a shape preferably ranging from round to oval, which is placed in concertina pleats (3), characterized in that the concertina pleats (3) are parallel to a direction of extension (2); and in that the concertina pleats (3) are fixed only approximately centrally as related to the selected direction of extension (2) by a fixing arrangement (4) that passes through the pleats in such a way that
    - the basic structure (6), in its undeformed position of rest, is approximately hourglass-shaped in a plan view.
  2. A prosthesis according to claim 1, characterized in that the fixing arrangement is a fixing thread (5) that is stitched through the pleated layers.
  3. A prosthesis according to claim 2, characterized in that the fixing seam (4) that is formed by the fixing thread (5) runs crosswise of the direction of extension (2) of the pleats and crosswise of the principal plane (H) of extension of the undeformed prosthesis.
  4. A prosthesis according to claim 2 or 3, characterized in that the thread of layer material and the fixing thread (5) consist of the same plastic material, preferably polypropylene, and have the same thread thickness, preferably 100 dtex.
  5. A prosthesis according to one of the preceding claims, characterized in that the basic structure (6) is fixed in its deformed, plug-type configuration by connection of adjoining lateral-edge areas (8).
  6. A prosthesis according to claim 5, characterized in that the connection of the adjoining lateral-edge areas (8) is produced by a seam (9), preferably of the same thread material as the layer-material thread.
  7. A prosthesis according to one of the preceding claims, characterized by a metal-containing, continuous, biocompatible coating.
  8. A prosthesis according to claim 7, characterized in that the coating is a titanium-containing coating of a thickness of less than 2 µm, preferably 5 to 700 nm.
  9. A prosthesis according to one of the preceding claims, characterized in that the layer material (1) for the basic structure (6) is laser-beam cut to size.
  10. A prosthesis according to one of the preceding claims, characterized in that two basic structures (6) are placed crosswise one on top of the other and joined to each other.
  11. A prosthesis according to one of the preceding claims, characterized in that the blank (10), not yet pleated, of the basic structure (6) has an outer contour ranging from round to oval with a constriction (11) of hourglass shape in the central area.
EP05707568A 2004-02-26 2005-02-22 Implantable prosthesis for repairing hernia defects Active EP1718239B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102004009892A DE102004009892A1 (en) 2004-02-26 2004-02-26 Implantable prosthesis for the repair of hernia defects
PCT/EP2005/001829 WO2005082273A1 (en) 2004-02-26 2005-02-22 Implantable prosthesis for repairing hernia defects

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EP1718239A1 EP1718239A1 (en) 2006-11-08
EP1718239B1 true EP1718239B1 (en) 2009-08-12

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US (1) US20080215071A1 (en)
EP (1) EP1718239B1 (en)
AT (1) ATE439098T1 (en)
DE (2) DE102004009892A1 (en)
WO (1) WO2005082273A1 (en)

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Also Published As

Publication number Publication date
DE502005007888D1 (en) 2009-09-24
DE102004009892A1 (en) 2005-09-15
EP1718239A1 (en) 2006-11-08
WO2005082273A1 (en) 2005-09-09
US20080215071A1 (en) 2008-09-04
ATE439098T1 (en) 2009-08-15

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